Conclusions From Completed Trials in Conclusions From Completed - - PowerPoint PPT Presentation

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Conclusions From Completed Trials in Conclusions From Completed - - PowerPoint PPT Presentation

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Conclusions From Completed Trials in Conclusions From Completed Trials in High Risk Carotid Stenting High Risk Carotid Stenting Jay S. Yadav MD Jay S. Yadav MD Chairman, CCF Innovations Chairman, CCF Innovations Director, Vascular

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YADAV YADAV YADAV YADAV

Conclusions From Completed Trials in Conclusions From Completed Trials in High Risk Carotid Stenting High Risk Carotid Stenting

Jay S. Yadav MD Jay S. Yadav MD

Chairman, CCF Innovations Chairman, CCF Innovations Director, Vascular Intervention Director, Vascular Intervention The Cleveland Clinic Foundation The Cleveland Clinic Foundation

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Randomized Data Randomized Data

◆ Carotid Endarterectomy – 1954*

Carotid Endarterectomy – 1954*

◆

40 years for proof of efficacy 40 years for proof of efficacy

◆ 1991 NASCET/ECST

1991 NASCET/ECST ◆ Carotid Artery Stenting – 1994

Carotid Artery Stenting – 1994

◆

2001 CAVATAS (angioplasty) 2001 CAVATAS (angioplasty)

◆

2002 SAPPHIRE 2002 SAPPHIRE

◆

2004 2004 FDA Approval FDA Approval

*Eastcott HH et al. Lancet 1954;267:994-996

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WENNBERG, JAMA,1998:16:279:1278

CEA Mortality CEA Mortality

0.0% 1.0% 2.0% 3.0%

ACAS NASCE T Trial Hospital s Non- trial Hospital s Low Volume Hospitals .1% .6% 1.4 % 1.7 % 2.5 %

Mortality

113,000 Medicare Patients (1992- 1993)

30 day follow- up

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YADAV YADAV YADAV YADAV

Surgery Intervention

  • Restenosis
  • XRT
  • Radical Neck
  • CN Palsies
  • Cardiac/Pulm
  • Pre-OHS
  • High/Low Lesions
  • Contralateral Occl
  • Elderly
  • String Signs
  • Thrombus
  • Acute Stroke
  • Tortuosity
  • Poor Access
  • Coag/Platelet
  • Severe Ca++
  • Arch Anatomy

High Risk Features High Risk Features

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YADAV YADAV YADAV YADAV

High-Risk Patient Trials: High-Risk Patient Trials:

Carotid Stenting with Emboli Protection Carotid Stenting with Emboli Protection

◆ Randomized against Surgery

Randomized against Surgery

◆

SAPPHIRE SAPPHIRE

◆ Non-Randomized Registries

Non-Randomized Registries

◆

ARCHER ARCHER

◆

SHELTER / BEACH SHELTER / BEACH

◆

MAVERICK MAVERICK

◆

CABERNET CABERNET

◆

SECURITY SECURITY

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YADAV YADAV YADAV YADAV

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YADAV YADAV YADAV YADAV

High-Risk Patient Trials: High-Risk Patient Trials: Data to be Presented at TCT Data to be Presented at TCT

◆ CAPTURE:

CAPTURE: Guidant PMS Study Guidant PMS Study Largest, prospective study to date Largest, prospective study to date

◆ SAPPHIRE

SAPPHIRE 3 Year Follow-up 3 Year Follow-up

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YADAV YADAV YADAV YADAV

SAPPHIRE STUDY: SAPPHIRE STUDY: Stroke Stroke at 360 Days at 360 Days

Yadav, NEJM,2004 Yadav, NEJM,2004

7.2 3.0 1.8 3.6 6.0 0.6 5 10 15 20 25 Stroke Major Ipsi Minor Ipsi CEA (n=167) Stent (n=167)

%

P=0.21 P=0.50 P=0.83

Note: 2/3 of all minor strokes resolved within one year. Note: 2/3 of all minor strokes resolved within one year.

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SAPPHIRE STUDY SAPPHIRE STUDY

MAE MAE at 360 Days at 360 Days

Rand CEA: 20.1% Non-Rand Stent: 16.0% Rand Stent: 12.2%

Non-Randomized Stent Arm vs. Randomized Stent & CEA

Time After Initial Procedure (days)

Cumulative Percentage of MAE

Rand CEA: 9.8% Non-Rand Stent: 6.9% Rand Stent: 4.8%

Yadav, NEJM,2004 Yadav, NEJM,2004

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YADAV YADAV YADAV YADAV

9.8% 4.8%

30

12.2% 20.1%

Days: 30 360 720 N at Risk (CEA): 161 125 59 N at Risk (Stent): 163 147 88

CEA 26.7% Stent 19.2%

SAPPHIRE STUDY SAPPHIRE STUDY

Cumulative % of Cumulative % of MAE MAE to 720 Days to 720 Days Randomized Patients – Kaplan Meier Analysis Randomized Patients – Kaplan Meier Analysis

Time After Initial Procedure (days)

Cumulative Percentage of MAE

9.8% 4.8% 12.2% 20.1% CEA 26.7% Stent 19.2%

Yadav, NEJM,2004 Yadav, NEJM,2004

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Days: 30 360 720 N at Risk (CEA): 159 130 59 N at Risk (Stent): 162 145 88

3.6% Stent 3.1% CEA

30

5.8% CEA 5.8% CEA 5.9% Stent 4.9% Stent * All Stroke to 30 days and ipsilateral stroke from 31-720 Days

SAPPHIRE STUDY SAPPHIRE STUDY

Cumulative % of Cumulative % of Stroke Stroke* to 720 Days * to 720 Days Randomized Patients - Kaplan Meier Analysis Randomized Patients - Kaplan Meier Analysis

Time After Initial Procedure (days)

Cumulative Percentage of Stroke

Yadav, NEJM,2004 Yadav, NEJM,2004 Yadav, NEJM,2004 Yadav, NEJM,2004

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YADAV YADAV YADAV YADAV

US US FEASIBILITY FEASIBILITY STUDY STUDY

Cumulative Percentage of Cumulative Percentage of All Stroke All Stroke to 30 Days and to 30 Days and Ipsilateral Stroke from 31-1080 Days Ipsilateral Stroke from 31-1080 Days

6.1% 7.3% 8.7% 8.7%

30

Days: 30 360 720 1080 N at Risk: 247 218 176 113

Time After Initial Procedure (days)

Cumulative Percentage of Stroke

Yadav, NEJM,2004 Yadav, NEJM,2004

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YADAV YADAV YADAV YADAV

High-Risk Patient Trials: High-Risk Patient Trials:

Carotid Stenting with Emboli Protection Carotid Stenting with Emboli Protection

◆ Difficult to Compare Even 30 Day Results

Difficult to Compare Even 30 Day Results

◆ Varying Definitions / Methodologies

Varying Definitions / Methodologies

◆ Inclusion of Device Failures

Inclusion of Device Failures

◆ All Stroke Vs Ipsilateral Stroke Vs Procedure

All Stroke Vs Ipsilateral Stroke Vs Procedure Related Stroke Related Stroke

◆ At 1 year, many do not count death or

At 1 year, many do not count death or count only neurological death count only neurological death

◆ Not Published (except SAPPHIRE)

Not Published (except SAPPHIRE)

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30 Day MAE-Composite Endpoint in 30 Day MAE-Composite Endpoint in High Risk Carotid Stenting Trials High Risk Carotid Stenting Trials

4.8% 3.8% 5.3% 5.4% 7.2% 8.3% 4.8%

0.0% 1.0% 2.0% 3.0% 4.0% 5.0% 6.0% 7.0% 8.0% 9.0%

SAPPHIRE NEJM ARCHER 2 IFU SECURITY TCT 2003 BEACH TCT 2004 MAVERIC II TCT 2004 CABERNET TCT 2004 CREATE SIR 2005

% of Patients

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30-Day Risk of Stroke in High Risk Carotid Stenting Trials

2 4 6 8

Patients (%)

3.1% 4.9% 5.8% 3.3% Ipsil

  • nly

4.2%

3.2% Device Only

6.2%

ARCHeR 2

SAPPHIRE

Rand Non-Rand SECuRITY BEACH Maveric 2 Cabernet Create

4.8% Proced contrala lat Only

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YADAV YADAV YADAV YADAV

30 Day Risk of Major Stroke in High 30 Day Risk of Major Stroke in High Risk Carotid Stenting Trials Risk Carotid Stenting Trials

1.1% 2.3% 1.0% 2.0% 2.3% 0.0% 1.4%

0.0% 1.0% 2.0% 3.0% 4.0% 5.0% 6.0% 7.0% 8.0%

CABERNET TCT 2004 SAPPHIRE NEJM CREATE SIR 2005 MAVERIC II TCT 2004 BEACH TCT 2004 SECURITY TCT 2003 ARCHER 2 IFU

% of Patients

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1 year clinically driven TLR in 1 year clinically driven TLR in High Risk Carotid Stenting Trials High Risk Carotid Stenting Trials

2.2% 0.7% 5.3% 0.6%

0.0% 1.0% 2.0% 3.0% 4.0% 5.0% 6.0% 7.0% 8.0%

CABERNET TCT 2004 SAPPHIRE NEJM CREATE SIR 2005 MAVERIC II TCT 2004 BEACH TCT 2004 SECURITY TCT 2003 ARCHER 2 IFU

% of Patients

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Carotid stenting with cerebral protection: Carotid stenting with cerebral protection:

Pooled analysis of perioperative outcomes Pooled analysis of perioperative outcomes

Yadav, Balzer, Beyssen, Cleveland, Cremonesi, Daoud Yadav, Balzer, Beyssen, Cleveland, Cremonesi, Daoud ◆ 32 studies of CEA, Stenting

32 studies of CEA, Stenting

◆ 30 Day Stroke/Death and

30 Day Stroke/Death and Stroke/MI/Death Stroke/MI/Death

◆ Cea

Cea 3369 pts 3369 pts

◆ PCAS

PCAS 1222 pts 1222 pts

◆ UPCAS

UPCAS 1638 pts 1638 pts

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Carotid stenting with cerebral protection: Carotid stenting with cerebral protection:

Pooled analysis of 30 Day perioperative outcomes Pooled analysis of 30 Day perioperative outcomes

Yadav, Balzer, Beyssen, Cleveland, Cremonesi, Daoud Yadav, Balzer, Beyssen, Cleveland, Cremonesi, Daoud TX TX # Pts # Pts Sx Pts (%) Sx Pts (%) S/D (%) S/D (%) S/D/MI(%) S/D/MI(%) CEA CEA 3,369 3,369 1,253 (62.8) 1,253 (62.8) 87 (2.6) 87 (2.6) 64 (2.8) 64 (2.8) PCAS PCAS 1,222 1,222 656 (46.3) 656 (46.3) 33 (2.7) 33 (2.7) 25 (2.6) 25 (2.6) UPCAS UPCAS 1,638 1,638 723 (55.9) 723 (55.9) 88 (5.4) 88 (5.4) 77 (6.1) 77 (6.1) ALL ALL 6,229 6,229 2,636 (57.7) 2,636 (57.7) 208 (3.3) 208 (3.3) 166 (3.7) 166 (3.7)

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YADAV YADAV YADAV YADAV

Carotid stenting with cerebral protection: Carotid stenting with cerebral protection:

Pooled analysis of 30 Day perioperative outcomes Pooled analysis of 30 Day perioperative outcomes

Yadav, Balzer, Beyssen, Cleveland, Cremonesi, Daoud Yadav, Balzer, Beyssen, Cleveland, Cremonesi, Daoud

Treatments Symptomatic patients [95% CI] 30-day stroke-death [95% CI] 30-day stroke-MI-death [95% CI] Endarterectomy 62.78% [61.15% ; 64.41%] 2.58% [2.05% ; 3.12%] 2.81% [2.25% ; 3.37%] Protected stenting 46.32% [43.52% ; 49.11%] 2.70% [1.79% ; 3.61%] 2.64% [1.74% ; 3.54%] Unprotected stenting 55.86% [53.46% ; 58.27%] 5.37% [4.28% ; 6.46%] 6.11% [4.95% ; 7.27%] Protected stenting versus Endarterectomy p-value >.82 p-value >.78 Protected stenting versus Unprotected stenting p-value <.00045 p-value <.00012

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Conclusions Conclusions

◆ One randomized study and many registries

One randomized study and many registries completed completed

◆ SAPPHIRE: superiority of protected stenting

SAPPHIRE: superiority of protected stenting

◆ Paucity of publications

Paucity of publications

◆ Variable endpoints / definitions

Variable endpoints / definitions

◆ No evidence of definite improvement in results

No evidence of definite improvement in results

◆ Meta-analysis indicates need for protection and

Meta-analysis indicates need for protection and equivalent results to CEA equivalent results to CEA